The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l
The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.
GGN,JPA
Plasma, Coagulation Control,System, Multipurpose For In Vitro Coagulation Studies
The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system in
The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses.Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected.
JPA
System, Multipurpose For In Vitro Coagulation Studies
The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system in
The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses.Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected.
JPA
System, Multipurpose For In Vitro Coagulation Studies
The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system in
The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses.Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected.
JPA
System, Multipurpose For In Vitro Coagulation Studies
The EXTEM assay is a semi-quantitative in vitro diagnostic assay used to monitor
The EXTEM assay is a semi-quantitative in vitro diagnostic assay used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM® delta. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). CFT and alpha (Speed of Clot Formation) are complementary parameters and should be used in conjunction with the main parameters Clotting Time (CT) and Clot Firmness (A20/MCF).
JPA
System, Multipurpose For In Vitro Coagulation Studies
ROTROL P is a quality control material for monitoring accuracy and precision of
ROTROL P is a quality control material for monitoring accuracy and precision of tests carried out on the ROTEM® delta Thromboelastometry System. For in vitro diagnostic use only.
GGN,JPA
Plasma, Coagulation Control,System, Multipurpose For In Vitro Coagulation Studies
ROTROL N is a quality control material for monitoring accuracy and precision of
ROTROL N is a quality control material for monitoring accuracy and precision of tests carried out on the ROTEM® delta Thromboelastometry System. For in vitro diagnostic use only.
JPA,GGN
System, Multipurpose For In Vitro Coagulation Studies,Plasma, Coagulation Control
The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l
The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environ-ment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve – clot firmness over time) and several defined numerical parameters describing the curve quantitatively.The star-tem® reagent is intended for use as recalcification reagent in the NATEM and INTEM assay on the ROTEM® delta. The corresponding assays are described in the NATEM assay application sheet and in the Instructions for Use of the in-tem® reagent (REF 503-02-US), resp.
GGN,JPA
Plasma, Coagulation Control,System, Multipurpose For In Vitro Coagulation Studies
The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l
The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environ-ment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.The hep-tem® assay is a semi-quantitative in vitro diagnostic assay used to inactivate heparin in patients receiving unfractionated heparin on the ROTEM® delta. To monitor the coagulation process citrated whole blood specimens are used. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)).
JPA,GGN
System, Multipurpose For In Vitro Coagulation Studies,Plasma, Coagulation Control
The FIBTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM®
The FIBTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the clot firmness of citrated whole blood specimens after blocking platelet contribution to the clot firmness. fib-tem® is always used in conjunction with ex-tem®. Clotting characteristics are described by the functional parameter Clot Firmness (A20/MCF).
JPA
System, Multipurpose For In Vitro Coagulation Studies
The APTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® d
The APTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the clot firmness of citrated whole blood specimens after blocking hyperfibrinolysis by aprotinin. ap-tem® is always used in conjunction with ex-tem®. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). CFT and alpha (Speed of Clot Formation) are complementary parameters and should be used in conjunction with the main parameters Clotting Time (CT) and Clot Firmness (A20/MCF).
JPA
System, Multipurpose For In Vitro Coagulation Studies
The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l
The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.The in-tem® assay is a semi-quantitative in vitro diagnostic assay used to monitor the coagulation process via the intrinsic pathway in citrated whole blood specimens on the ROTEM® delta. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)).
GGN,JPA
Plasma, Coagulation Control,System, Multipurpose For In Vitro Coagulation Studies
The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l
The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.
JPA,GGN
System, Multipurpose For In Vitro Coagulation Studies,Plasma, Coagulation Control
The Reference Plasma Quality Control Kit is for use with the Sonoclot® Analyzer
The Reference Plasma Quality Control Kit is for use with the Sonoclot® Analyzer System to verify performance of activated cuvettes. Testing should be performed prior to the use of a new shipment of activated cuvettes and monthly throughout use of the stock. More frequent testing may be required to comply with local, state and federal QC requirements. Reference plasma quality control is important to properly verify proper performance of coagulation test activators. A two level testing approach is used to perform quality control of the activator used in an activated coagulation test. Level I is run with the activator on the reference plasma. Level II is run with the non-activated test on the reference plasma. These two tests confirm the effectiveness of the activator to perform its intended coagulation activation.Each Kit contains:1 vial Reference Plasma Control - 6 ml vial containing a lyophilized preparation of citrated animal plasma, stabilizers and buffer. Contains no human material.1 vial Distilled Water - 6 ml vial containing 5.0 ml laboratory grade distilled water.1 vial 0.02 M Calcium Chloride - 6 ml vial containing 5.0 ml 0.02 M Calcium Chloride.5 plastic 1 ml syringes2 non-activated test cuvettes (blue with clear caps, stir bars, and probes)
The Reference Viscosity Oil QC test is a simple means of verifying proper operat
The Reference Viscosity Oil QC test is a simple means of verifying proper operation of the Sonoclot Analyzer. This test consists of a two point verification of the electromechanical oscillator and also ensures that the heating control is operating accurately. The two verification points are: 1) Probe-In-Air, and 2) Probe-In-Oil. The Probe-In-Air is the response of the electromechanical oscillator to air. The Probe-In-Oil is the response of the electromechanical oscillator to the reference viscosity liquid. Since the viscosity of the reference viscosity fluid is significantly temperature dependent, the Probe-In-Oil test point also verifies the temperature regulation. The QC test should be run each day the Sonoclot Analyzer is used or as required by your institution. Each Reference Viscosity Quality Control Kit contains 24 cuvettes, 24 probes, 1 vial of reference viscosity oil with end cap, and these instructions. These supplies provide 24 QC tests for the analyzer.
Sonoclot® Reference Viscosity Oil Quality Control Kit
The SonACT Kit is an in vitro diagnostic reagent for use with the Sonoclot® Coag
The SonACT Kit is an in vitro diagnostic reagent for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The SonACT test is a celite activated whole blood clotting time test. It may also be used with citrated whole blood and plasma. The SonACT Kit is intended for general purpose global hemostasis monitoring including: clot detection, fibrin formation, platelet function, and hyperfibrinolysis. The monitoring information is typically used for anticoagulant management up to high heparin levels (0 to approximately 6 units per ml), hypercoagulable and/or hypocoagulable screening, platelet function assessment, and hyperfibrinolysis screening. When used with the Sonoclot Analyzer System, the SonACT test provides quantitative Onset/ACT and Clot Rate results as well as qualitative and quantitative information on the Sonoclot Signature including: fibrin formation, platelet function, and hyperfibrinolysis.Each kit contains 100 lidded colorless plastic activation cuvettes, 100 probes, and instructions for use. The activation cuvettes contain a controlled amount of celite and a magnetic stir bar.
The SonACT Kit is an in vitro diagnostic reagent for use with the Sonoclot® Coag
The SonACT Kit is an in vitro diagnostic reagent for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The SonACT test is a celite activated whole blood clotting time test. It may also be used with citrated whole blood and plasma. The SonACT Kit is intended for general purpose global hemostasis monitoring including: clot detection, fibrin formation, platelet function, and hyperfibrinolysis. The monitoring information is typically used for anticoagulant management up to high heparin levels (0 to approximately 6 units per ml), hypercoagulable and/or hypocoagulable screening, platelet function assessment, and hyperfibrinolysis screening. When used with the Sonoclot Analyzer System, the SonACT test provides quantitative Onset/ACT and Clot Rate results as well as qualitative and quantitative information on the Sonoclot Signature including: fibrin formation, platelet function, and hyperfibrinolysis.Each kit contains 24 lidded colorless plastic activation cuvettes, 24 probes, and instructions for use. The activation cuvettes contain a controlled amount of celite and a magnetic stir bar.
The Non-Activated Clotting Test Kit contains the necessary components for an in
The Non-Activated Clotting Test Kit contains the necessary components for an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. It may be used with native whole blood, citrated whole blood, and plasma. The Non-Activated Kit may either be used as a non-activated clotting test or as a general use test with user provided activators. It is intended for customer designed hemostasis monitoring on the Sonoclot Analyzer. The Non-Activated cuvette allows for coagulation monitoring using tissue activation, thrombin activation, and other custom activators. Some of the applications for the Non-Activated test with the addition of customer determined reagents are monitoring of fibrin formation, fibrinolysis, hyperfibrinolysis and clot retraction. When used with the Sonoclot Analyzer System, the Non-Activated test provides quantitative Onset/ACT and Clot Rate results as well as qualitative and quantitative information on the Sonoclot Signature including: fibrin formation, platelet function, and hyperfibrinolysis. Each kit contains 24 lidded plastic cuvettes, 24 probes, and instructions for use. The cuvettes contain a magnetic stir bar.
The Non-Activated Clotting Test Kit contains the necessary components for an in
The Non-Activated Clotting Test Kit contains the necessary components for an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. It may be used with native whole blood, citrated whole blood, and plasma. The Non-Activated Kit may either be used as a non-activated clotting test or as a general use test with user provided activators. It is intended for customer designed hemostasis monitoring on the Sonoclot Analyzer. The Non-Activated cuvette allows for coagulation monitoring using tissue activation, thrombin activation, and other custom activators. Some of the applications for the Non-Activated test with the addition of customer determined reagents are monitoring of fibrin formation, fibrinolysis, hyperfibrinolysis and clot retraction. When used with the Sonoclot Analyzer System, the Non-Activated test provides quantitative Onset/ACT and Clot Rate results as well as qualitative and quantitative information on the Sonoclot Signature including: fibrin formation, platelet function, and hyperfibrinolysis. Each kit contains 100 lidded plastic cuvettes, 100 probes, and instructions for use. The cuvettes contain a magnetic stir bar.
The kACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulat
The kACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The kACT test is a kaolin activated whole blood clotting time test. It may also be used with citrated whole blood and plasma. The kACT Kit is intended for high dose heparin management with or without aprotinin. The kACT test provides quantitative Onset/ACT and Clot Rate results with the Sonoclot Analyzer. The kACT test is not intended for platelet function monitoring. Each kit contains 24 lidded blue plastic activation cuvettes, 24 probes, and instructions for use. The activation cuvettes contain a controlled amount of kaolin and a magnetic stir bar.
The kACT Kit is an in vitro diagnostic test for use with the Sonoclot Coagulatio
The kACT Kit is an in vitro diagnostic test for use with the Sonoclot Coagulation & Platelet Function Analyzer System. The kACT test is a kaolin activated whole blood clotting time test. It may also be used with citrated whole blood and plasma.The kACT kit is intended for high dose heparin management with or without aprotinin. The kACT test provides quantitative Onset/ACT and Clot Rate results with the Sonoclot Analyzer. The kACT test is not intended for platelet function monitoring.Each kACT Kit contains 100 lidded blue plastic activation cuvettes, 100 probes, and instructions for use. The activation cuvettes contain a controlled amount of kaolin and a magnetic stir bar.